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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,398 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,398 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,398 FDA device recalls in NY.

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DateProductReasonClassFirm
Apr 15, 2016 IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insu... 24 minutes of incubation is required prior to processing patient samples and for the pretreatment... Class II Siemens Healthcare Diagnostics, Inc.
Apr 15, 2016 CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490... Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita... Class II Carestream Health Inc
Apr 15, 2016 CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1... Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita... Class II Carestream Health Inc
Apr 6, 2016 VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in... Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... Class II Ortho-Clinical Diagnostics
Apr 6, 2016 VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifi... Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... Class II Ortho-Clinical Diagnostics
Mar 30, 2016 ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710,... The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two ina... Class III Siemens Healthcare Diagnostics, Inc.
Mar 30, 2016 AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./... The product lot did not meet sterility requirements based on FDA sampling and analysis. Class II Amd-Ritmed, Inc.
Mar 21, 2016 AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870,... Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 21, 2016 Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Us... Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 17, 2016 enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec... The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l... Class II Ortho-Clinical Diagnostics
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Ki... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M0014... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN ... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H96595... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H96595... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M0014... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55c... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & ... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, R... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels:... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H9654... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, ... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 14, 2016 Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H96... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Mar 10, 2016 ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD ... Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology S... Class II Siemens Healthcare Diagnostics, Inc.
Mar 10, 2016 HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles,... On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,... Class II Repro-Med Systems, Inc.
Mar 10, 2016 Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60,... On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,... Class II Repro-Med Systems, Inc.
Mar 7, 2016 ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 1069757... Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagen... Class II Siemens Healthcare Diagnostics, Inc.
Mar 3, 2016 dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Sea... Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in ... Class II Dynarex Corporation
Mar 3, 2016 Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 The seal between the balloon and the housing may leak. Class II Circulatory Technology Inc
Mar 2, 2016 IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK... Possible presence of foreign material (rust). Class II CMP Industries, Llc
Feb 18, 2016 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique ... When testing was conducted using certain lots, VITROS¿ Systems generated results within the measu... Class II Ortho-Clinical Diagnostics
Feb 17, 2016 EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum c... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Universal aluminum crutch, 1 pair per case Aid the user in walking while r... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walk... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 17, 2016 Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... Tip crutch failure involving the bottom of the metal portion which comes in contact with ground Class II Medical Depot Inc.
Feb 16, 2016 VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & ... The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situ... Class II Ortho-Clinical Diagnostics
Feb 12, 2016 Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and He... Complaints were received claiming the material failed to polymerize under the curing light. Afte... Class II Ivoclar Vivadent, Inc.
Jan 14, 2016 BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in v... False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... Class II Siemens Healthcare Diagnostics, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.